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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 03 MAY 1976 to 06 MAY 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Fed. Reg. Vol. 38, No. 187, p. 27019, 1973
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
61932-63-6
Test material form:
solid: nanoform, no surface treatment
Details on test material:
Name of test material (as cited in study report): Permanentrot F6RK CM 86745
Analytical purity: 45.1 % (w/w) (comp. 1) Pigment Red 170, 53.6 % (w/w) (comp. 2) Pigment Red 266

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: single
- Diet: standard diet (ERKA 8300, Futtermittelwerke Robert Koch , Hamm. Germany), ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: basically in accordance with OECD TG 405.
Scores were read 1, 7, 24, 48 and 72 h after test substance application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 48 and 72 h reading

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Irritant / corrosive response data:
- no iridial or corneal effects were visible at any time point.
- in the 1 h reading 1/6 animal showed an conjunctivae redness score of 1. This effect was completely reversible within 7 h.
- no chemosis was observed at any time point.
- discharge scores for animal #1,2,3,4,5,6 after 1 h: (0,1,1,1,0,1), after 7 h: (0,1,0,1,0,0), after 24 h: (0,0,0,1,0,0). After 48 and 72 h scores for all animals were 0.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritating to eyes in all animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. Therefore, it is concluded that the submission substance is not irritating to eyes.
Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals each. The eyes were washed 24 h after application and eye responses were noted for 72 h. Only very slight effects were visible. After 1 h discharge was observed in 4/6 animals and conjunctivae redness in 1/6 animals. Conjunctivae redness was completely reversible within 7 h. Discharge was completely reversible within 48 h. No corneal or iridial effects were visible at any time point as well as no chemosis. Therefore, it is concluded that the submission substance is not irritating to eyes.

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